Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Trophoblastic Neoplasms

Choriocarcinoma

Trophoblastic Tumor, Placental Site

Gestational Trophoblastic Disease

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Pregnancy Complications

Pregnancy Complications, Neoplastic

Urogenital Diseases

Female Urogenital Diseases

Female Urogenital Diseases and Pregnancy Complications

Gestational Trophoblastic Tumor

Antineoplastic Agents

All Drugs and Chemicals

Vasodilator Agents

Bevacizumab

Antibodies

Nitroglycerin

Angiogenesis Inhibitors

Immunoglobulins

Antineoplastic Agents, Immunological

Growth Inhibitors

All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.

Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.

TRC105

Bevacizumab will be dosed every two weeks.

Charles Theuer, MD, PhD

The purpose of the study is to determine the overall response rate of single agent TRC105 and the combination of TRC105 and bevacizumab in patients with refractory GTN (including choriocarcinoma, placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT)). Up to 30 patients will be treated.

TRC105 is a monoclonal antibody that binds to endoglin, an angiogenic target highly expressed on the tumor vessels and tumor cells in gestational trophoblastic neoplasia (GTN). Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) that inhibits angiogenesis and extends survival in patients with a wide variety of solid tumor types. TRC105 has been well tolerated as a single agent and when combined with bevacizumab. These antibodies may be efficacious in refractory GTN, a tumor type that is highly vascular and has been shown to densely express endoglin.

Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

A Phase 2A Study of TRC105 (With Option to Add Bevacizumab) in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)

Antitumor Activity of Single Agent TRC105 and the Combination of TRC105 and Bevacizumab will be assessed via RECIST 1.1 and by measuring circulating bHCG. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.

Median Progression-Free Survival (PFS) via Serum hCG levels and response evaluation according to RECIST version 1.1 as a preliminary measure of the antitumor activity of TRC105. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks. Patients must have screening (baseline) and at least one on study CT scan to be considered evaluable.

Overall Response Rate on bevacizumab alone according to RECIST 1.1 in combination with serum hCG levels. Disease progression is defined as \>20% increase (the absolute increase must be ≥10 IU/L) above the nadir on consecutive measurements separated by at least two weeks; Partial response is defined as a hCG decrease of 50% or more from starting value on consecutive measurements; Complete response will be defined as normalization of hCG on consecutive measurements separated by at least two weeks; Stable disease will be defined as the absence of response or progression on 3 consecutive measurements separated by at least two weeks.

Mean serum TRC105 concentrations were assessed at cycle 1 and cycle 2 on day 1, 8, 15, and 22 and on day 1 of every subsequent cycle using validated methods in order to determine the Cmax of TRC105

Anti-Product Antibody (APA) concentrations will be measured using validated ELISA methods at the time points specified in the protocol. APA concentrations will be evaluated in the context of pharmacokinetic parameters and AE profiles. Number of patients with positive APA titers on study will be reported.

Determine frequency and severity of adverse events as assessed by NCI CTCAE (Version 4.03)

Tracon Pharmaceuticals Inc.

All subjects will begin by receiving single agent TRC105 weekly. In the case of a complete response to single agent TRC105, subjects will continue to receive single agent TRC105 for at least 3 months following complete response. In the case of a partial response (without a complete response) to single agent TRC105, bevacizumab every two weeks will be added. In the absence of a partial or complete response to single agent TRC105, subjects will receive single agent bevacizumab every two weeks. In the absence of a complete response to single agent bevacizumab, or for subjects who have documented disease progression on a prior bevacizumab containing regimen, subjects will receive TRC105 weekly and bevacizumab every two weeks.

TRC105: Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.

Bevacizumab: Bevacizumab will be dosed every two weeks.

TRC105 and/or Bevacizumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Number of Prior Regimens

Medical Monitor

Number of patients with best response of PR

Number of patients with best response of SD

Number of patients with best response of PD

Number of patients with best response of CR

All patients who had a baseline scan and at least 1 on study assessment

Overall Response Rate on TRC105 Alone and on the Combination of TRC105 and Bevacizumab

Progression-Free Survival (PFS)

Overall Response Rate on Bevacizumab Alone

Maximum Plasma Concentration (Cmax) of TRC105.

TRC105 Immunogenicity as Assessed by Anti-Product Antibody (APA).

Participants who experienced an SAE

Participants who experienced a TRC105 related SAE

Frequency and Severity of Adverse Events

Overall Study

Hydatidiform Mole

Nevus

In single evacuation group women will be treated by suction evacuation and curettage is performed at the end of evacuation in one sitting. An ultrasound will be done later to examine completeness of evacuation. If there is significant amount of residual molar tissue or persistence of heavy bleeding a repeat curettage will be done . Women will be followed up with serum beta hcg 1 week after the evacuation and then weekly till the titer is negative. After three consecutive negative titre beat HCG estimation will be done at two weekly interval.

Suction and evacuation

In double evacuation group , women will be treated by suction evacuation and a thorough curettage will be avoided. A second evacuation with thorough curettage will be performed after 5 - 7 days of first evacuation.

Snehamay Chaudhuri, MD, DNB

Hydatidiform mole is a common complication of pregnancy with an incidence of 1in 400 pregnancies in India. Although this is a benign condition , it is having the malignant potential too. A repeat curettage after evacuation of hydatidiform mole was generally advocated till 1990s. A thorough curettage at the time of initial evacuation was not performed because of larger size of uterus and risk of perforation. Subsequently a number of studies assessed the usefulness of repeat curettage and found it was unnecessary and not cost effective . However all these studies are retrospective in design and conducted in developed countries where hydatidiform mole is diagnosed earlier because of wider use of ultrasonography. Thus there is a need to perform a well designed prospective study to compare the effectiveness of single evacuation with double evacuation in treatment of hydatidiform mole for prevention of Gestational Trophoblastic Neoplasia.This study compares the effectiveness of single evacuation versus double evacuation for treatment of hydatidiform mole for prevention of gestational trophoblastic neoplasia .

A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole

A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform

Nilratan Sircar Medical College

Associate Professor,Obstetrics and Gynecology, NRS Medical College

Patients with a diagnosis of Gestational Trophoblastic Neoplasia who completed chemotherapy treatment between 6 weeks and 24 months prior to the study. No IMP intervention to be administered, patients to be involved in a qualitative interview.

Kamaljit Singh

Grace Cole

Daniel Habershon

A cross-sectional retrospective study of a sample of 20 women who completed single agent or multi agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi structured telephone interview. A patient sample of 20 is proposed for the study. These are all the patients who meet the inclusion criteria below and are thus eligible for the study. These patients will be contacted via telephone by the principal investigator to inform them of the study and invite participation. A proposed sample size of 20 is sufficient to generate data to address the central questions and furthermore, this sample size is adequate because the intention is to gain insight into the experiences of patients' perceptions about their psychological experiences.

Objectives:

* Gaining insight into the emotional impact of GTN post treatment
* Ascertaining if health professionals are providing adequate psychological support
* Identifying sources of support that patients accessed post completion of treatment
* Identifying potential areas of improvement in the follow up support for future patients

Criteria for inclusion:

* Treated with chemotherapy for a GTN diagnosis
* Completed treatment between 6 weeks and 24 months
* Are able to provide informed consent
* Have no cognitive impairment as judged by the treating clinician

Criteria for exclusion

* Treatment received less than 6 weeks ago
* Treatment received more than 24 months ago
* Non-English speaking

Outcome measures are not appropriate in this qualitative study. However outputs from this study include increasing knowledge and insight into:

* patients' experiences of their psychological experiences post chemotherapy
* patients' perspective of the support received after their treatment
* potential areas of improvements in care

Research question:

What is the psychological impact on women with GTN who have completed chemotherapy treatment?

Objectives:

* Gaining insight into the emotional impact of GTN post treatment
* Ascertaining if health professionals are providing adequate psychological support
* Identifying sources of support that patients accessed post completion of treatment
* Identifying potential areas of improvement in the follow up support for future patients

Abstract:

Gestational Trophoblastic Neoplasia is highly curative but can have psychological consequences for women due to the nature of the diagnosis. Little is known about the psychological impact of diagnosis and treatment experienced by women following the completion of treatment. As the specialist centre for GTN in the North of the UK, it is important to understand the experiences and care needs of our patients. The aim of the study is to explore women's experiences following treatment, how they managed any negative impacts and investigate if there is gap in the follow up support provided to patients after treatment.

The study aims to have 20 participants who received chemotherapy. Semi-structured telephone interviews will be conducted; each interview will be digitally recorded and transcribed verbatim. Thematic analysis will be used to generate in depth descriptions of the patients experiences. The findings will enable health care professionals working closely with this unique group of patients to gain some understanding of the patient perspective; recommendations will be made to improve the support and provision of care these patients receive after their treatment has completed.

Aim:

The aim of the study is to explore the experiences of women with GTN following completion of chemotherapy

Plan of investigation:

Methodology A cross-sectional retrospective study of a sample of 20 women who completed single agent or multi agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi structured telephone interview. This is felt to be appropriate as this topic has received very little research attention for this rare disease and the study aims to capture the patients' own descriptions of their symptoms and experiences. The timeline will capture different perspectives from the varying treatments that patients received, this may provide valuablet insight into patient experiences during different time points.

Telephone interviews will be conducted to gain insight into the patient's experiences. The rationale for using the telephone method is based on the geographical location of our patients. It is not feasible for the investigators to travel to individual homes to conduct the interviews or ask patients to travel. This method has the advantage in that it is relatively inexpensive. The telephone interview offers a robust method of eliciting information from patients about the quality of their care which could help to design improved services. The telephone interviews were designed following discussions with the clinical team and with the aim of answering the research question.

Setting All interviews will be recorded via telephone and take place at Weston Park Hospital. The principal investigator will be responsible for negotiating dates and times of the interview and contacting the participants the day before to ensure they are still available for the scheduled interview. The principal investigator will ensure a designated quiet room is available for the interviews without any interruptions. Each interview will be digitally recorded and transcribed verbatim using an external company- Lawson Hardwick Limited 1st class secretarial services. An hour will be allocated for each interview.

Sample A patient sample of 20 is proposed for the study. These are all the patients who meet the inclusion criteria below and are thus eligible for the study. These patients will be contacted via telephone by the principal investigator to inform them of the study and invite participation. A proposal of 20 is sufficient to generate data to address the central questions and furthermore, this sample size is adequate because the intention is to gain insight into the experiences of patients' perceptions about their psychological experiences.

Criteria for inclusion:

* Treated with chemotherapy for a GTN diagnosis
* Completed treatment between 6 weeks and 24 months
* Are able to provide informed consent
* Have no cognitive impairment as judged by the treating clinician

Criteria for exclusion

* Treatment received less than 6 weeks ago
* Treatment received more than 24 months ago
* Non-English speaking

Recruitment Each of the participants will receive a written information leaflet via email with the details of the nature of study and a written consent form for them to sign and return. The principal investigator will be responsible for contacting the patients once the consent forms have been returned to discuss the study and answer any questions. The interview schedule will be sent prior to the interviews. This will enable them to think about what they would like to say, and importantly, offer them the opportunity to tell their experience in depth.

Intervention:

* Patients are selected as potential participants from the GTN database by the principal investigator
* Patients are contacted by the principal investigation via telephone to invite them to the study
* Patients are emailed the information leaflet along with the written consent form to return back
* If the patients consent to participate in the study the chief investigator will contact participants to discuss
* An interview will be arranged at a time and date convenient to both the patient and the investigator

Outcome measures Outcome measures are not appropriate in this qualitative study. However outputs from this study include increasing knowledge and insight into:

* patients' experiences of their psychological experiences post chemotherapy
* patients' perspective of the support received after their treatment
* potential areas of improvements in care

Analysis Thematic analysis will be used to generate in depth descriptions of the patients experiences. This process of analysis involves looking for themes which are present in the interviews and making comparisons and contrasts between the different respondents. The thematic analysis will be carried out by three investigators. Independent analysis will be carried out separately then meetings will be scheduled to analyse and discuss any agreements and discrepancies to ensure reliability of the interpretations of the data.

Data Collection Data will be collected using telephone semi structured interviews; the interview schedule was developed using the expertise from the research team and on the basis of the aims of the study.

Ethical and safety issues The risks associated with this project are minimal. There are no medical or invasive procedures involved. Therefore, this study does not envisage any harm to be caused to the participant and it is unlikely that the study will encounter any adverse events. It is felt that contacting the patients to invite them to participate is a justified method because the centre has built an excellent rapport with their patients. These patients received treatment at Weston Park Hospital over a number of months; over this period, they have built good trusting relationships with their clinical nurse specialists. Furthermore, these patients continue to be followed up in clinic and via telephone after the treatment has completed. It is possible that the nature of data collection, focusing on personal experiences, may result in some distress to some participants. Both the clinical and research team have extensive experience of caring for patients with cancer. The researchers have relevant experience in working in cancer care and are skilled at talking to patients and will be able to recognise patient distress. If necessary, and with the patients consent, other supportive networks will be made available. The research team will have direct access to the clinical nurse specialist team and be able to refer patients back to their allocated CNS (with the participant's consent).

Patients who agree to participate in the study will be emailed an information sheet explaining the nature of the study and what it entails. Participants will need to sign and return the consent form. It is noted that there may be recall bias as some patients who received treatment almost 24 months ago may not have any symptoms, or not recall in detail compared to those patients who have completed their treatment less than 6 months ago. The use of telephone and email is deemed appropriate as patients often use this method to contact their nursing team and all emails are provided on registration.

There is a potential that during the interview a participant mentions an aspect of care that raises concern regarding care quality, client safety or negligence. If this occurs the study team member will act accordingly, and act follow refer back to the appropriate service provider or care professional.

Subject Withdrawal:

Participants will be able to withdraw from the study at any point; their data will be disposed of using the trust guidelines. If there is sufficient data generated then the study will continue.

Confidentiality All study data including the interview recordings and transcriptions will be identifiable only by an ID number which will be assigned on signing the consent form. Any identifying details will be removed and the transcriptions will be anonymous. The data will be stored securely and confidentially. The interviews will be conducted in a private quiet room. All study data will be stored securely and confidentially in accordance with the Data Protection Act 2018. The data will be kept in locked cupboards and on password protected computers at each of the Trust's centres. The data will be securely kept for future research on the Trust's computer with a secured password.

Involvement of service users:

Two patients who will not be participating in the study have been involved in reviewing the interview questions.

Strategy for taking the work forward if the research project is productive:

The results will be disseminated within the MDT and presented at the next European meeting and International Society for the Study of Trophoblastic Diseases conference in 2024. The findings will enable health care professionals working closely with this unique group of patients to gain some understanding of the patient perspective and importantly improve the patient experience, furthermore, gaining a close insight and improving their own knowledge.

Intellectual property arrangements:

The intellectual property arrangements will be standard for research conducted in the NHS and funded within charitable sources.

End of study definition The study will end when all the data is analysed.

GTN affects the female reproductive organs, and as such only those with female biological anatomy. Therefore, only those of female biological sex would meet the eligibility criteria.

The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment

Thematic analysis will be used to interpret common themes of patient experiences following chemotherapy for GTN

Thematic analysis will be used to interpret common patient perspectives of the support received after their treatment

Thematic analysis will be used to interpret common suggestions of how patient care can be improved for those receiving chemotherapy for GTN.

Sheffield Teaching Hospitals NHS Foundation Trust

Substance Related Disorders

Drug-Related Side Effects and Adverse Reactions

Chemically-Induced Disorders

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Anti-Infective Agents

Micronutrients

Hematinics

Vitamins

Methotrexate

Dactinomycin

Antimetabolites

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Folinic Acid

Folate

Vitamin B9

single methotrexate multicourse treatment MTX:MTX 0.4mg/kg•d, intramuscular, every two weeks

combination of methotrexate and actinomycin multicourse treatment, every two weeks MTX+ACTD:Act-d 0.6mg/m2 Day1,2 intravenous (IV) MTX 100mg/m2 IV Day1(after Act-d) MTX 200mg/m2 Ivgtt Day1(after MTX,500mlNS)

combination use of methotrexate and actinomycin

MTX+ACTD

Weiguo Lu, MD.

Lili Chen, PhD.

Weiguo Lv, Doctor

In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.

The improved prognostic scoring system has been in use for more than 20 years in GTN patients. However, there are also more and more clinical evidences showing that the International Federation of Obstetrics and Gynecology（FIGO）/world health organization (WHO) system is not so perfect. The main problem is that a considerable number of patients are resistant to initial chemotherapy, 25-35% occur in low risk (≤ 6 points), and 70-80% occur in patients with a score of 5-6 points. According to reference, the drug resistance factors include high HCG level before chemotherapy, metastatic foci, histological diagnosis of choriocarcinoma, etc. However, according to the score before 2000, there is a moderate risk score group with 4-6 points, i.e. most of the single drug resistance to the initial regimen occurs in the previous moderate risk score group.Therefore, most scholars believe that there are grey areas with a score of 5-6. According to the analysis of 5-6 scores in the scoring system, the prognosis of single-drug chemotherapy is poor, and the initial remission rate is only about 30-40%. Therefore, many authors call for the current staging scoring system to be revised to a more accurate model so that some patients who may be drug resistant can adopt more effective plans at the beginning of treatment.

In this study, the investigators plan to conduct a prospective, multicenter randomized controlled study to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen. The experiment arm of the trial is multi-course combination of MTX and ACTD. The primary endpoint is complete remission rate of primary treatment or failure of primary treatment. Drug toxicity is surveillanced.

treatment by combination of methotrexate and actinomycin

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of TRC105 and Bevacizumab in Patients With Refractory Gestational Trophoblastic Neoplasia (GTN)	NCT02664961	Gestational Tro... Choriocarcinoma Placental Site ... Epithelioid Tro...	TRC105 Bevacizumab	16 Years - 99 Years	Tracon Pharmaceuticals Inc.
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole	NCT01630954	Hydatidiform Mo...	Suction and eva... Suction and eva...	15 Years - 45 Years	Nilratan Sircar Medical College
The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment	NCT06169644	Gestational Tro...		16 Years - 55 Years	Sheffield Teaching Hospitals NHS Foundation Trust
Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6	NCT03885388	Gestational Tro... Effects of Chem... Drug Toxicity	MTX MTX+ACTD	18 Years - 60 Years	Women's Hospital School Of Medicine Zhejiang University
A Comparison of Single Versus Double Evacuation for Treatment of Hydatidiform Mole	NCT01630954	Hydatidiform Mo...	Suction and eva... Suction and eva...	15 Years - 45 Years	Nilratan Sircar Medical College
The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment	NCT06169644	Gestational Tro...		16 Years - 55 Years	Sheffield Teaching Hospitals NHS Foundation Trust

Spots Global Cancer Trial Database for gtn

Every month we try and update this database with for gtn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for gtn

Every month we try and update this database with for gtn cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for gtn cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.